Tag: new drug application

I might be over-exaggerating, but I’ve always thought that the anti-vaccine religion believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Despite the fact that pharmaceutical drug development is so complicated and failure-prone, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device fly through this process, with Big Pharma’s lust for profits taking precedence over science.

The myths about pharmaceutical drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies), and does whatever it wants. But let’s look at the process of pharmaceutical drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts of pharmaceutical drug development.

I might be over-exaggerating, but I’ve always thought that the anti-vaccine religion believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Despite the fact that pharmaceutical drug development is so complicated and failure-prone, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device fly through this process, with Big Pharma’s lust for profits taking precedence over science.

The myths about pharmaceutical drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies), and does whatever it wants. But let’s look at the process of pharmaceutical drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths of from the facts of pharmaceutical drug development.